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Recall Observatory FDA recall evidence

Device product

Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

Z-1551-2025

March 11, 2025

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 96440
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1551-2025

Official wording

Reason: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

Code information: Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots.

Distribution pattern: Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark,¿Estonia, Finland, France, Germany, Greece,¿Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Netherlands, New Zealand, Norway, Oman,¿Pakistan, Poland, Portugal, Qatar, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan, U.A.E., Uganda, United¿Kingdom, Uzbekistan, Vatikancity.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Incorrect software